Efficacy & Safety Study of Bilateral IVT Injection of GS010 in LHON Subjects Due to the ND4 Mutation for up to 1 Year
Completed · Phase 3 · Has a placebo group
Conditions studied: Leber Hereditary Optic Neuropathy
In brief
The goal of this clinical trial is to assess the efficacy and safety of GS010 gene therapy - (lenadogene nolparvovec) in subjects with LHON due to the G11778A ND4 mitochondrial mutation with a vision loss up to one year.
Key facts
- Study ID
- NCT03293524
- Run by
- GenSight Biologics
- People needed
- 98
- Starts
- 2018-03-12
- Expected to finish
- 2024-07-23
- Last updated by the study team
- 2026-04-16
Who can join
Age: 15 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Doheny Eye Center UCLA Pasadena — Pasadena, California, United States
- University of Colorado Health Eye Center — Aurora, Colorado, United States
- Emory Healthcare - The Emory Clinic — Atlanta, Georgia, United States
- Massachusetts Eye and Ear Infirmary — Boston, Massachusetts, United States
- Department of Ophthalmology, Icahn School of Medicine at Mount Sinai — New York, New York, United States
- Departments of Neurology and Ophthalmology, Wills Eye Hospital and Thomas Jefferson University — Philadelphia, Pennsylvania, United States
- Vanderbilt Eye Institute — Nashville, Tennessee, United States
- Universitair Ziekenhuis Gent — Ghent, Belgium
- CHNO Les Quinze Vingts — Paris, Paris, France
- IRCCS Istituto delle Scienze Neurologiche di Bologna (ISNB) Clinica Neurologica — Bologna, Italy
- Hospital Universitario Ramon y Cajal — Madrid, Spain
- Taipei Veterans General Hospital — Taipei, Taiwan
- Moorfields Eye Hospital — London, Greater London, United Kingdom
Full record on ClinicalTrials.gov
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